The following data is part of a premarket notification filed by Howmedica Osteonics, Dba Stryker Orthopaedics with the FDA for Artisan Bone Plug, Universal Cement Restrictor.
| Device ID | K220838 |
| 510k Number | K220838 |
| Device Name: | Artisan Bone Plug, Universal Cement Restrictor |
| Classification | Cement Obturator |
| Applicant | Howmedica Osteonics, Dba Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Margaret Klippel |
| Correspondent | Margaret Klippel Howmedica Osteonics, Dba Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-22 |
| Decision Date | 2022-05-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327036695 | K220838 | 000 |
| 07613327036671 | K220838 | 000 |
| 07613327036664 | K220838 | 000 |